Systemic AmyloidosisPhase 2NCT06342466
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
A Phase 2 study testing Bortezomib, Pomalidomide and Dexamethasone in people with Systemic Amyloidosis, run by Jin Lu, MD at 1 site in China.
Trial summary
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Amyloidosis
- What is being tested?
- Bortezomib, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
- Newly diagnosed or previous treated AL amyloidosis
- Patients must be ≥ 18 years of age.
- ECOG performance status 0, 1 or 2.
- Measurable disease defined by at least one of the following:
- ① serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).
Show all 12Show fewer
- ②. presence of a monoclonal spike that is ≥5 g/l.
- Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
- Absolute neutrophil count (ANC) ≥1.0 X 10^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10^9/L
- eGFR ≥20 mL/min/ 1.73 m^2
- Written informed consent in accordance with local and institutional guidelines.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
- Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, +8613716926210, pkuphliuyang@bjmu.edu.cn
Jin Lu
About this study
Official title: A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.
Read the detailed description
Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.
- Conditions
- Systemic Amyloidosis
- Being tested
- Bortezomib, Pomalidomide, Dexamethasone
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
Bortezomib 1.3mg/m2 sc weekly
PomalidomideDrug
4mg per day taken orally on 1-21 of repeated 28-day cycles
DexamethasoneDrug
Dexamethasone 20mg-40mg weekly
| Study group | Role | What they receive |
|---|---|---|
| BPd | Experimental | BPd regimen (Bortezomib, pomalidomide, and dexamethasone) will be applied every 28 days until progression of disease, unacceptable toxicity or subsequent therapy, for a maximum of six cycles. Receives: Drug: Bortezomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic VGPR + CR rate at 6 months
Hematologic very good partial response plus complete response rate at 6 months
Measured: 6 months
Secondary outcomes (6)
Overall Hematologic response rate at 6 months
Overall Hematologic partial response, very good partial response rate and complete response at 6 months
Measured: 6 months
At least one organ response at 6 months
At least one organ response (cardiac response, renal response, liver response) at 6 months
Measured: 6 months
TTNT at 2 years
Time to next treatment at 2 years
Measured: 2 years
Estimated PFS at 2 years
Estimated Progression free survival at 2 years
Measured: 2 years
Estimated OS at 2 years
Estimated Overall Survival at 2 years
Measured: 2 years
TRAE
Treatment-related adverse events up to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start6 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bortezomib, pomalidomide, dexamethasone
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Lu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342466
- Sponsor's protocol ID
- 2023-358-02
- Status last verified
- May 2024
- First submitted
- 19 Mar 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No